SPL v1
SPL
SPL Set ID 777ecbd3-9577-421d-b476-0bb7726b3120
Route
TOPICAL
Published
Effective Date 2017-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.98 g) Octinoxate (0.91 g) Zinc Cation (0.12 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-01

Description

Active ingredients: Titanium Dioxide 7.60%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Gently press the pull on the air cushion and pat it onto your skin

Warnings

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Active Ingredient

Active ingredients: Titanium Dioxide 7.60%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dimethicone, PEG-10 Dimethicone, Cetyl Ethylhexanoate, Cyclohexasiloxane,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Diisostearyl Malate, Niacinamide, Polypropylsilsesquioxane, Boron Nitride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Chloride, Iron Oxides (CI 77492), Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Disteardimonium Hectorite, Iron Oxides (CI 77491), Decyl Glucoside , Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77499), Polysilicone-11, Glyceryl Acrylate/Acrylic Acid Copolymer, Ethylhexylglycerin, Adenosine, Propylene Glycol, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Allantoin, Fragrance

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children.

Description (DESCRIPTION)

Uses: - Helps prevent sunburn. - If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Directions: Gently press the pull on the air cushion and pat it onto your skin

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 7.60%, Ethylhexyl Methoxycinnamate 7.00%, Zinc Oxide 0.98%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, Dimethicone, PEG-10 Dimethicone, Cetyl Ethylhexanoate, Cyclohexasiloxane,Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Diisostearyl Malate, Niacinamide, Polypropylsilsesquioxane, Boron Nitride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, 1,2-Hexanediol, Glycerin, Sodium Chloride, Iron Oxides (CI 77492), Aloe Barbadensis Leaf Juice, Biosaccharide Gum-1, Disteardimonium Hectorite, Iron Oxides (CI 77491), Decyl Glucoside , Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol, Tocopheryl Acetate, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77499), Polysilicone-11, Glyceryl Acrylate/Acrylic Acid Copolymer, Ethylhexylglycerin, Adenosine, Propylene Glycol, Disodium EDTA, Xanthan Gum, Sophora Japonica Fruit Extract, Allantoin, Fragrance

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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